CSV Engineer: MES Validation in GxP Pharma

Katalyst CRO; Bothell (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead validation activities for GxP computerized systems, with a strong focus on MES in a pharmaceutical setting.

The ideal candidate will manage CSV lifecycle activities, develop validation documents, and ensure compliance with GAMP, 21 CFR Part 11, and GDP while collaborating with QA, Manufacturing, IT, and business owners to deliver audit-ready systems.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or related discipline.
• 4+ years of CSV experience in a GxP-regulated pharmaceutical/biotech manufacturing environment.
• Strong MES validation experience (e.g., Emerson Syncade).
• Solid knowledge of CSV principles, validation lifecycle, and regulatory standards (GAMP, 21 CFR Part 11, GDP).

Responsibilities

• Lead and execute CSV activities across validation lifecycle for GxP systems and applications.
• Develop, review, execute, and maintain CSV documentation (IQ/OQ/PQ, URS, Validation Plans, SOPs).
• Support MES validation and ensure regulatory compliance.
• Collaborate with QA, Manufacturing, IT, and Business Owners to develop validation deliverables.

Skills

CSV lifecycle

GAMP 5

21 CFR Part 11

UAT

Technical writing

Education

Bachelor's degree in Life Sciences or related field

Tools

Emerson Syncade

SAP

Oracle

InfoBatch

Veeva

ServiceNow

Job description

Katalyst CRO is seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead validation activities for GxP computerized systems, with a strong focus on MES in a pharmaceutical setting.

The ideal candidate will manage CSV lifecycle activities, develop validation documents, and ensure compliance with GAMP, 21 CFR Part 11, and GDP while collaborating with QA, Manufacturing, IT, and business owners to deliver audit-ready systems.